Trials / Recruiting
RecruitingNCT05887700
Lifetech CeraFlex™ ASD Closure System Post-Market Clinical Follow-Up
A Multi-center, Single-arm, Real-world Registry Assessing the Clinical Use of the Lifetech CeraFlex™ ASD Closure System
- Status
- Recruiting
- Phase
- —
- Study type
- Observational
- Enrollment
- 145 (estimated)
- Sponsor
- Lifetech Scientific (Shenzhen) Co., Ltd. · Industry
- Sex
- All
- Age
- —
- Healthy volunteers
- Not accepted
Summary
The objective of this post-market registry is to assess the clinical use of the Lifetech CeraFlex™ Closure System in a real-world and on-label fashion.
Detailed description
The study intends to collect data from patients who have implanted with the device between 2019 and 2022. The data collection process is expected to complete by end of 2024. Final report shall be available in 2025.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | CeraFlex™ Atrial Septal Defect (ASD) Closure System | The CeraFlex™ ASD Occluder have two types of occluders, CeraFlex™ ASD Occluder and CeraFlex™ Multi-fenestrated (Cribriform) ASD Occluder. The CeraFlex™ ASD Occluder is percutaneous, transcatheter closure devices for the non-surgical closure of atrial septal defects. |
Timeline
- Start date
- 2024-07-09
- Primary completion
- 2027-12-01
- Completion
- 2027-12-01
- First posted
- 2023-06-05
- Last updated
- 2025-01-08
Locations
7 sites across 3 countries: Brazil, Greece, Italy
Source: ClinicalTrials.gov record NCT05887700. Inclusion in this directory is not an endorsement.